483sOnline Subscribe

Search By Date Issued

Search By Category

Drug
Device
Clinical

Search By Company/

Clinical Investigator

Search By Region

Search By FDA Investigator

Search By Keyword

Log in to start searching through our library of thousands of 483s, or Subscribe Now to 483sOnline.com to uncover exactly what FDA Inspectors are thinking about. It’s your own personal pre-investigation intelligence tool that identifies exactly what investigators are focusing on so you can be prepared – before they show up.

Unysen Health, Inc. - March 27, 2019

Issue Date

Mar 27, 2019

Region

Southwest

Category

Device
$117.00

Unysen Health, Inc.

Contact Name

Noel Cyrill

Contact Title

Chief Operating Officer

Form483 Address 1

400 Industrial Blvd.

Form483 Address 2

Form483 City

Mansfield

Form483 State

TX

Form483 Postal

76063-2204

Form483 Country

United States

Inspection Range

Mar 25, 2019 - Mar 27, 2019

Pages

3

First Observation

Individuals who conduct quality audits have direct responsibility for the matters being audited.
Investigator(s): Jeremy L. Stukes